MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET; DH CPK NG TUBES

Model Number	20-9366
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 11 nov 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).
Event or Problem Description
It was noted at 10pm that there was milk coming out from near the hub of the feeding tube.The patient was receiving serum glucose at 50mg/dl on continuous oral digestive tube (odt) feeding, 12ml/hour.The patient's serum glucose was "at 30's at start of shift due to odt needed to be reinserted and verified by x-ray" at 7pm.Patient has history of hypoglycemia.Due to the leak, a new tube was attempted to be inserted by a neonatal nurse practitioner (nnp), twice, unsuccessfully.Instead the tube was place nasogastrically (ngt), and placement was confirmed with x-ray.Serum glucose was then monitored every 15 mins, every 30 mins then hourly x2 until stable.Serum glucose stabilized when ngt feeding resumed.Per additional information received 5 nov 2020, the odt had been in place for 1 3/4 hours prior to the feeding tube leaking.
Additional Manufacturer Narrative
The device history record for lot 30033022 was reviewed and the product was produced according to product specifications.One used sample was returned for evaluation.The sample was infused with water and a tear/hole was identified which caused the tube to leak.Inspection under magnification revealed dent marks around the area of the hole.The area where the uneven surface appeared jagged and/or wrinkled.The tubing was cut to view the inside surface of the tubing.Once the tubing was opened, there were lines, indentations and loose particles in the inner walls of the tubing.The complaint is confirmed as reported, however, no definite root cause could be determined.A review of the manufacturing process did not reveal any activities or tools that could cause the damage observed.Per the instructions for use for the device, vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.All information reasonably known as of 11 jan 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10829800
• Report Number: 9611594-2020-00218
• Device Sequence Number: 19589372
• Product Code: KNT
• UDI-Device Identifier: 00350770457857
• UDI-Public: 00350770457857
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2025
• Device Model Number: 20-9366
• Device Catalogue Number: N/A
• Device Lot Number: 30033022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 01/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 MO